Verisante announced today that the first of the Aura commercial models have been delivered.
This is a fantastic looking machine in my opinion.
Have a look at the photographs here: facebook.com/verisante
The second half of 2012 will be an exciting journey for this company.
Good luck to all.
The IDE while it MAY be necessary is not a particularly telling milestone as far as the subsequent timing and likelihood of FDA approval. Unless I'm mistaken, MELA was not even required to obtain an IDE because it was viewed by the original FDA reviewers as low risk. That makes it even more odd that the later misguided FDA reviewer was characterizing it as quite risky.
Of course he was doing this based on faulty assumptions, most notably that derms were near 100% sensitive on their own, (they aren't) and that an answer of unevaluable would be viewed by derms as equivalent to an answer of "all clear from melanoma"
you should concur with the report in the proper context 'to support government funding for patient scanning with the aura in Italy by the government health authority' -this is to be expected by a government body.
Where is there assessment about melafind?
Will a government be anxious to support a device to which the FDA is on record fearing that this device will likely increase needless biopsies......
I also would like to see more independent research using both the Aura and Melafind in actual clinical practice.
This will come in due time. Choose wisely.
just my thoughts.
I didn't even see Italy's comments on melafind - maybe you have this?
I've read (several times) the AACR publication.
You might like to read the conclusion from the Agenis report you previously touted. They basically say more independent research is needed for Aura. Do you think the FDA would give an indication for melanoma screening when only 44 melanoma lesions were included in the above publication, and there was no comparator and blinding is qustionable?
I concur with your Agenis report--more research is needed for Aura
Contrast with Mela--Mela has pivotal studies published, data reviewed by the FDA and approved for marketing and commercialization process underway with units being sold.
roundhouse - the independent 6 year study published by Cancer Research on Mar.15/12
Author: Dr. Harvey Lui
Department of Dermatology and Skin Science
University of British Columbia
This study fully qualifies with FDA requirements and UBC has all required accreditations for the study to be used by the FDA for the PMA process. Will additional data be required? possibly - but sales start later this year as will additional Aura studies in all approved markets - additonal data will be flowing soon.
Also - as an investor I expect to see some info on the VRSEF FDA IDE (investigative device exemption) application progress as well....
just my thoughts.
By that time Melafind will quite possibly be modified to recognize other forms of skin cancer and also the Melameter mod. In addition, Melafind will be entrenched in the Derms practice and can't imagine a Derm putting up a 70K out pocket expense up front for Verisante.
Electricsoc is living in dream land if he believes that his pumping will delay MELA's progression and acceptance by Derms. The Derm community is not going to put MELA on hold waiting for the possibility of something else coming three years from now and a much greater up front cost.
Verisante does not have an indication in the US because it has not done the studies and is not approved for sale by the US FDA. You are looking at several years before approval.
b767cpt1 - wrong
Verisante Aura description from the corporate website:
Aura™ is indicated for use for the evaluation of skin lesions that may be clinically suspicious for melanoma, squamous cell carcinoma, basal cell carcinoma, and/or actinic keratosis when a medical professional chooses to obtain additional information to rule out one of the above conditions before making a final decision to biopsy. The device will help to automate the current process of diagnosis, allowing rapid scanning of the 20 to 40 skin lesions on at-risk individuals, improving patient outcomes and comfort.
Melafind description via their website:
MelaFind was designed by dermatologists and is ONLY for dermatologists. Clinically proven to have a very high sensitivity to melanoma and high grade lesions, MelaFind® offers dermatologists objective information about the 3-dimensional morphological disorganization of atypical pigmented skin lesions from under the skin.
These are two very very different devices using completely unique technology to each other.
Here's an additional yahoo / zacks update out today on this stock:
Assuming VRSEF works as advertised, all it will provide is a quick answer on if a mole is cancer. Something that Melafind will also provide in addition, Melameter mod will provide the the Derms with much more information.